MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	CXT201412
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, the patient underwent an endovascular aortic repair (evar) procedure to treat a dissection in the left distal common iliac artery utilizing a gore® excluder® conformable aaa endoprosthesis, two gore® excluder® aaa endoprosthesis, two gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn® device) and two gore® viabahn® vbx balloon expandable endoprosthesis (vbx stent).Reportedly, patient had a tortuous aortic neck and during initial wire access there was a dissection noted in the visceral segment, this was resolved and covered with the conformable main body graft.The procedure went well with all devices implanted.At the end of the procedure, it was uncertain but there was a possible type 3 endoleak from the parallel vbx stents that were inserted in the hypogastric and external iliac arteries on the patient's left side.Physician decided to wait and see if the endoleak resolved on its own, or review on the ct at next follow up to confirm exact location of the leak.On (b)(6) 2025, the patient was brought back for an emergent procedure to treat the retrograde dissection from above the trunk ipsilateral leg conformable graft near the renal arteries and up to the left subclavian artery (lsa).It is noted that it was a new dissection that potentially was created during the wire access prior to placement of the gore sheaths at the beginning of the original evar procedure.The dissection and endoleak remained, hence, physician decided to explant all devices that were implanted and did an open surgical repair.The explanted devices were discarded.On march 30, 2025, the field sales associate was notified of the explant event.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and/or require intervention include, but are not limited to dissection and surgical cut down, bypass or conversion.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21913661
• Report Number: 3007284313-2025-03931
• Device Sequence Number: 18412335
• Product Code: MIH
• UDI-Device Identifier: 00733132650996
• UDI-Public: (01)00733132650996(17)271028
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CXT201412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown